随机分配簿:实现临床试验随机分配遮蔽的新技术  

Using random allocation book for random allocation concealment in a clinical trial

作　　者：钟伟华[1] 陆梦洁[1] 刘玉秀[1] 刘甜甜[1] 周敏林[2] 

机构地区：[1]南方医科大学金陵医院(南京军区南京总医院)医务部,南京医学硕士研究生210002 [2]南京军区南京总医院国家肾脏疾病临床医学研究中心全军肾脏病研究所,南京210002

出　　处：《医学研究生学报》2017年第1期91-94,共4页Journal of Medical Postgraduates

基　　金：国家自然科学基金(81473066)

摘　　要：目的随机分配遮蔽对保证高质量的随机对照临床试验(RCT)具有重要意义。文中通过对信封法随机分配遮蔽技术的改进,以期设计一种更为便捷、有效的两联单随机分配遮蔽方法。方法根据产生的随机分配序列,为每一受试者制作一份随机分配两联单,并按顺序装订成册,制作成带有封面和使用说明的随机分配簿。两联单的第一联为说明联,第二联为分配联,两联序号相同、四周密封胶联,并在两联的相同区域处留空用于签署受试者信息。第一联书写的内容可完全复写至第二联上;第二联分配信息的背面涂黑印刷,避免透光识别而导致分配信息的提前破解。当研究者确定受试者合格后,依先后顺序选择受试者对应的两联单。在第一联签署受试者信息后沿周边撕开暴露第二联分配信息,并将该受试者分配至第二联上所指定的组别。随机分配薄可委托专业印刷机构。按照随机分配序列表,并在严格的质量控制下印刷制作,对于多中心临床试验可分中心独立印制。结果该方法已在18项临床试验中得到应用,其中5项为多中心试验,3项为产品注册试验。结论两联单随机分配簿方法制作容易、操作简单、监查方便,可有效实现临床试验随机分配遮蔽,对确保随机化质量具有较强的实用价值。Objective Random allocation concealment is important in ensuring high-guality randomized controlled clinical trial. In this paper,we aimed to design a more convenient and effective two couplet random allocation method through improving the random allocation concealment technology which uses the envelope method. Methods According to the randomized sequence,a twocouplet random allocation should be prepared for every subject and bound into a book in order,which named random assignment book with cover and instructions. The first couplet is to collect the enroll information and the second couplet is to show the allocation information. The serial numbers of the two couplets which around sealant are the same,and leave blank at the same areas of the two couplets for signing the enter information. The content of the first couplet can be completely copied to the second couplet. In order to avoid exposing the allocation information in advance,the back of the second couplet should be black-printed. When the subjects are sure qualified,the researchers selected the corresponding two couplet in a sequential order. Exposing the allocation infromation in the second couplet,and the subjects will be allocated to the group designated on the second couplet. This random allocation book should be entrusted to professional printing mechanism,printing according to the random assignment sequence table and in the strict quality control. For the multicenter clinical trials,it can be printed in parts. Results The method has been implemented in nearly ten randomized controlled trials and obtained the consistent high praise. Conclusion The random allocation book method is easy to produce,simple operation and convenient in monitoring,which can effectively achieve the random allocation concealment in a clinical trial as well as having a significantly practical value in ensuring the quality of randomization.

关 键 词：随机对照临床试验 随机分配 分配遮蔽 信封法 两联单 

分 类 号：R195[医药卫生—卫生统计学]